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OSHA Hazard Information Bulletins
Regarding Inspection of Laboratories Conducting Biotechnical Research and Development


July 10, 1986

MEMORANDUM FOR:

REGIONAL ADMINISTRATORS

THRU:

  • JOHN B. MILES
  • Director
  • Directorate of Field Operations

FROM:

  • EDWARD J. BAIER
  • Director
  • Directorate of Technical Support

SUBJECT:

  • Health Hazard Information Regarding Inspection of Laboratories Conducting Biotechnical Research and Development

The information which follows was brought to our attention by Linda Anku, Regional Administrator, Region III. Our purpose is to alert OSHA field staff to the hazards associated with exposure to viral, bacterial and other pathogenic agents found in biotechnical research and development and suggest precautions to be implemented by compliance officers when inspecting such facilities.

In October 1985, two spills of HTLV-III virus (AIDS virus) occurred at Bionetics Research, Inc. located in Rockville, Maryland. This laboratory centrifuges, deactivates and ships the deactivated virus to other laboratories that produce AIDS antibody detection kits. The laboratory is licensed by the U.S. Department of Health and Human Services and follows Biosafety Level 3 practices as specified in a DCD/NIH publication entitled "Biosafety in Microbiological and Biomedical Laboratories," J.H. Richardson and W.E. Barkley (eds.) GP0 #017-023-00167-1 and HHS (CDC)#84-8395 (excerpts attached).

Both spills were caused by overpressurization of the harvesting equipment which caused in the first instance the separation of flexible tubing from its appropriate position. This separation caused the release of the virus onto the lab room floor. The separation was caused by the lack of a pressure regulator on the line and the absence of a pressure relief valve. The second incident involved the shattering of a glass vessel. In this instance, an employee was cut by the flying glass. A pressure regulator was operating when this spill occurred and the investigators are not certain why the glass vessel shattered. Following these incidents, the Maryland Department of Health and Mental Hygiene's Laboratories Administration and the State of Maryland Division of Labor and Industry Occupational Safety and Health (MOSH) inspected this facility (reports attached). Based upon inspections performed by these agencies, the following changes in process were recommended.

  1. Established standard operating procedures with periodic review.
  2. Replace pressurized system with mechanical pump system with pressure relief valves.
  3. Replace glass vessels with stainless steel or other appropriate vessels.
  4. Test run equipment before going on line.
  5. Train employees.

When investigating operations involving pathogenic agents, Compliance Officers should be aware of the modes of transmission of the particular agents. When the mode of transmission is known, the Compliance Officer should take appropriate precautions to minimize exposure to any pathogenic agent. For example, if the agent is transmitted through the aerosol route, appropriate respiratory protection is warranted. It is our recommendation that CSHOs wear gloves and cover areas of the body that have open lesions with appropriate barrier garments during laboratory inspections as a minimum precaution. a As guideline, we recommend following the precautions suggested in the CDC - NIH manual on laboratories that were cited earlier.

Additional questions concerning this topic should be directed to:

  • Dr. Robert W. McKinney Chief of OSH Branch Division of Safety Bldg. 13, Room 3K04A Bethesda, Maryland 20205 Telephone: (301) 496-2960 or,
  • Dr. Harry Mahar Chief of Technical Assistance Section OSH Branch Bldg. 13, Rm. 3K05 Bethesda, Maryland 20205 Telephone: (301)496-3353

References:

  1. "Biosafety in Microbiological and Biomedical Laboratories," CDC-NIH, March 1984, GOP #017-023--00167-1, HHS No. 84-8395.
  2. Federal Register, Vol. 49, No. 201, Tuesday, October 16, 1984.
  3. Morbidity and Mortality Weekly Report (MMWR), April 11, 1986, Vol. 35, No. 14, "Recommendations for Preventing Transmission of Infection with HTLH III/LAV during Invasive Procedures."
  4. MMWR, April 18, 1986, Vol. 35, No. 15, "Recommendation Infection - Control Practices for Denistry."
  5. MMWR, November 15, 1985, Vol. 34, No. 45, "Recommendations for Preventing Transmission of Infection with HTLV-III/LAV in the Workplace."
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